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prime concern: Biotechnology
GM Bill — Food for thought
The Biotechnology Regulatory Authority of India Bill has triggered a hot debate on the regulation and safety of genetically modified crops, with the AIADMK, TDP and BJD seeking its withdrawal. The Bill’s supporters say it’s the way to go, but those resisting it claim states’ rights will be eroded.
By Vibha Sharma
T
he introduction of the Biotechnology Regulatory Authority of India (BRAI) in the second half of the Budget session has again sparked a raging debate on genetically modified organisms (GMOs). The Bill seeks to set up an independent authority for regulating research, transport, import, manufacture and use of organisms and products of modern biotechnology, and was introduced in the Lok Sabha by Science and Technology Minister Jaipal Reddy amid protests by CPM leader Basudev Acharia, which got lost in the ongoing pandemonium on political issues.

for
No ailment linked to genetic produce
T
he very premise of the Bill is to ensure biosafety given the fact that India is a signatory to the UN Convention on Biological Diversity and the Cartagena Protocol on Biosafety. The authorisation process of undertaking research on activities listed in the schedule provides adequate safeguards for research. The Bill has a provision to create dedicated divisions to deal with activities related to agriculture, human and animal health and environment, says Ram Kaundinya, chairman of ABLE-AG.


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INTERVIEW

against
Food security a myth
A
ctivists say India’s regulatory system has been found wanting on many fronts and only active engagement by civil society and scientists, judiciary and policy makers slowed down the opening of floodgates for “potentially risky GM crops”. They say while Brazil, the US and Canada are following a permissive system, China has opted for a more precautionary approach as reflected in the new draft grain law that proposes to stop any genetic modification of staple crops.





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prime concern: Biotechnology
GM Bill — Food for thought
The Biotechnology Regulatory Authority of India Bill has triggered a hot debate on the regulation and safety of genetically modified crops, with the AIADMK, TDP and BJD seeking its withdrawal. The Bill’s supporters say it’s the way to go, but those resisting it claim states’ rights will be eroded.
By Vibha Sharma


Thinkstock photos

The introduction of the Biotechnology Regulatory Authority of India (BRAI) in the second half of the Budget session has again sparked a raging debate on genetically modified organisms (GMOs). The Bill seeks to set up an independent authority for regulating research, transport, import, manufacture and use of organisms and products of modern biotechnology, and was introduced in the Lok Sabha by Science and Technology Minister Jaipal Reddy amid protests by CPM leader Basudev Acharia, which got lost in the ongoing pandemonium on political issues.

Acharia calls the BRAI Bill “fundamentally flawed” as it has the wrong mandate of promoting modern technology like GM crops rather than safeguarding biosecurity against potential adverse effects of such products. Also, there is a conflict of interest as the proposed authority will be under the Science and Technology Ministry, which also has a mandate to promote biotechnology. “The Bill states it is in compliance with the Cartagena Protocol on Biosafety, which India is a signatory to, but its spirit does not suggest so,” he says.

Political discomfort

The CPM is also accusing the UPA of “striking closed-door deals with multinational companies without considering the need of the nation”. The AIADMK, TDP and BJD have sought for the withdrawal of the Bill as it is “contentious in nature and will allow single-window clearance mechanism for GM crops without proper safety assessments and lack of transparency. The department-related standing committee also recommended that BRAI was not the way forward for regulating GM crops in the country”.

Greenpeace and the Coalition for a GM-Free India (both NGOs) have also criticised the initiative of the government to set up a “seamless process” for the regulation of modern biotechnology. They allege it is a mechanism to push GM crops in India and “rob” states of their constitutional rights on agriculture and health.

“It is anti-farmer and anti-consumer, and if passed will only result in people losing control over food choices and seed sovereignty,” Pankaj Bhushan of the coalition says.

“The regulatory authority will act as a single-window clearance system for smoothening approval of GMOs, overlooking the ever-increasing evidence on their impact on human health, biodiversity and socioeconomic aspects or any long-term assessment to prove their safety. The moratorium on Bt (Bacillus thuringiensis) brinjal and the Parliament committee’s report proves the need for cautionary approach towards GM crops,” he adds.

Greenpeace campaigner Neha Saigal alleges the Bill was drafted secretively, giving no opportunity to the general public to comment on an issue that deals with an in important issue like food safety. “Stringent regulation built on a precautionary model is needed for a risky technology like GMOs, but BRAI is not the answer. What is needed is a biosafety protection regime that will put interests and welfare of citizens before profits of the industry. Most importantly, the regulation should protect health, biodiversity and farming from adverse impacts of GMOs,” she says.

Complex issue

Aruna Roy, member of the all-powerful Sonia Gandhi-led National Development Council, has also submitted her concerns to the UPA chairperson. But the contentious legislation has support from farmer organisations like the Consortium of Indian Farmers Associations (CIFA) and the related industry. They accuse activists of working at the behest of foreign countries and compromising India’s food security and self-sufficiency by hindering a legislation promoting modern biotechnology.

CIFA secretary-general P Chengal Reddy terms BRAI a “positive” effort that will take India forward. “We are already importing soya oil from Brazil so GMOs are very much a part of our food chain. Cotton seed oil from Bt cotton is also a part of our kitchens. Those opposing BRAI are not farmers, so they do not understand its relevance,” he claims.

Reddy says an independent regulatory authority will give confidence to the private sector and foreign investors to increase investments and enable farmers to become globally competitive by adopting the latest biotechnology tools.

He gets support from Ram Kaundinya, chairman of the Association of Biotech Led Enterprises-Agriculture Group (ABLE-AG), who assures that the precautionary principle built in the protocol is well reflected in the Bill. “Activists seem to oppose any workable system — Genetic Engineering Appraisal Committee, or even an evolved one. Is there any interest in science-based regulation or is the interest limited to non-stop ideological opposition in light of farmers’ widespread adoption?” he questions.

“The definition of modern biotechnology in the Bill is taken from the Cartagena Protocol and the authorisation process of undertaking research work on activities listed in the schedule provide adequate safeguards for conducting research,” he says. The Genetic Engineering Appraisal Committee under the Ministry of Environment and Forests and Review Committee on Genetic Manipulation under the department of biotechnology regulate genetically modified research.

GM technology is a complicated issue and a cause of confrontation between ministries. Agriculture Minister Sharad Pawar’s pitch for GM crops is well known. He cautions against “misplaced apprehensions” against scientifically proven developments like GM crops. He had locked horns with Jairam Ramesh after his decision to impose a moratorium on the commercial release of Bt brinjal, India’s first GM crop. Ramesh’s call as the Environment Minister is credited to “NGO influence”.

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for
No ailment linked to genetic produce

The very premise of the Bill is to ensure biosafety given the fact that India is a signatory to the UN Convention on Biological Diversity and the Cartagena Protocol on Biosafety. The authorisation process of undertaking research on activities listed in the schedule provides adequate safeguards for research. The Bill has a provision to create dedicated divisions to deal with activities related to agriculture, human and animal health and environment, says Ram Kaundinya, chairman of ABLE-AG.

Chapter VIII of the draft Bill deals with the creation and functions of the State Biotechnology Regulatory Advisory Committee, which will “act as the nodal agency for interaction between states and the authority in respect of matters related to the regulation of modern biotechnology under this Act and the rules and regulations made there under, therefore it is a fallacious belief that the autonomy of the states would be done away with,” he says.

The Bill has a provision to create an independent appellate authority to deal with disputes, hence it will not cause any burden on civil courts. “Penalties are stringent, but for activists no Act is good,” he maintains. On the activists’ charge that the Bill does not provide scope for independent research, he says the authority will designate institutions to generate the required information. “Throughout the world, data generated by accredited institutions (public or private) will be accepted by the regulatory authorities,” he says.

Regarding the conflict of interest of the department of biotechnology (DBT), he says the authority’s dependence on the DBT will be limited to finance and submitting an annual report in Parliament. “It promotes research in several areas, including agriculture. The Ministry of Agriculture does not support research in agriculture, including transgenic crops, the Science and Technology Ministry does. If not having a conflict of interest is the hallmark of independence, the government should not regulate anything or conduct any research,” he argues.

Misleading drive

He also trashes activists’ contention of the legislation catering to interests of the MNCs, calling them “false, baseless and frivolous”. “The Bill is focused on streamlining the procedure of development of GMOs in agriculture and the pharmaceutical sector and their safety assessments. More research is happening in public-funded institutions than in private bodies,” he says. So far, no ailment has been reported, empirically linked it to GMOs. “It is being propagated by scientists and groups who are determined to provide misinformation to the public on GM crops. Contrary to what the activists may say, acreage under Bt crops continues to grow, as does the acceptance by farmers and consumers,” Kaundinya says.

CIFA secretary-general P Chengal Reddy says in 2012, the US consumption of biotech soya bean was 93 per cent, cotton 94 per cent, maize 88 per cent, canola 93 per cent and sugar beet 97 per cent. “GM crops are consumed directly and indirectly by every citizen in the US. India’s 3 million NRIs and those visiting the US also eat genetic food. Dr Manmohan Singh and other VIPs visiting the US also have genetic food during their stay like 10 million Europeans visiting the US. Neither Europeans nor Indians have complained of cancer or impotency as propagated by Indian NGOs,” he emphasises.

Bt cotton success

According to Reddy, the present regulatory system (GEAC) is comprehensive, but “apprehensions created mischievously led to casting aspirations on research institutions, scientists and the regulatory authority. The success of Bt cotton indicates the present research and regulations are scientific and helpful to farmers.”

The Bill has taken care of all aspects. Details pertaining to research, evaluation and approvals of a particular GMO can be obtained by anyone. The Constitution provides powers to the High Courts and the Supreme Court to question any research project approved by the government. However, filing a case against the decision of the regulatory authority must be supported by substantial scientific evidence.

Irresponsible and false accusations against the authority’s decisions are subject to legal action, he adds.

The Bill
It seeks to promote the safe use of modern biotechnology by enhancing the effectiveness and efficiency of regulatory procedures and provide for the establishment of the Biotechnology Regulatory Authority of India to regulate research, transport, import, manufacture and use of organisms and products of modern biotechnology and related matters.

Checks in place
Adequate research safeguards in Bill.
Provision to create divisions to deal with activities related to agriculture, human and animal health, and environment.
Regulatory autonomy of states not threatened.
Dependence on department of biotechnology to be limited to finance, submission of annual report in Parliament.
Focus on streamlining procedure for development of GMOs and safety assessments.

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against
Food security a myth

Activists say India’s regulatory system has been found wanting on many fronts and only active engagement by civil society and scientists, judiciary and policy makers slowed down the opening of floodgates for “potentially risky GM crops”. They say while Brazil, the US and Canada are following a permissive system, China has opted for a more precautionary approach as reflected in the new draft grain law that proposes to stop any genetic modification of staple crops.


Grey areas
Regulatory system wanting on many fronts.
Need for biosafety protection authority instead of biotechnology regulatory authority.
Bill overlooks increasing evidence on health, biodiversity and socioeconomic aspects.
Department of biotechnology can’t be a regulator as it funds development of GMOs.
Developers of GM crops not permitting progress towards other technologies and practices like agroecology.

“There is a need for regulating GMOs and related products, but the mandate of the regulation should be biosafety protection and not promotion of products of modern biotechnology as is being proposed by BRAI. The standing committee also pointed to the need for a biosafety protection authority instead of a biotechnology regulatory authority with a limited agenda,” says Bhushan.

Regulatory system

Greenpeace activist Neha Saigal says a good regulatory system would be a precautionary type adopted by China and the EU and not the approval model as followed in the US because of the risk associated with environmental release of GMOs. “While the current regulatory system under the GEAC has the right mandate to protect biosafety, this is not well established in the rules,” she says.

Activists say the problems with the technology, particularly in food and farming systems where GMOs are released into the environment, are widely known and documented, but the Bill overlooks the ever-increasing evidence on human health, biodiversity and socioeconomic aspects. Even after 30 years of development and 19 years of commercialisation, GM crops cover less than 4 per cent of the total global cultivated area and is majorly limited to just soya, cotton, corn and canola; and in three countries — the US, Brazil and Argentina.

“Supporting the Bill would mean accepting a single-window approval mechanism for GM crops in the country without proper safety assessment and transparency, thereby risking food and farming,” Neha says.

Trashing the observation of the pro-GM group that the success of Bt cotton proved the efficacy of regulatory authorities in India, she talks of evidences of its failure in rain-fed regions. “The decline in productivity of cotton in the past few years was acknowledged by Minister of State Charan Das Mahant. It is the failure and inefficiency of our regulatory system which allows biotech companies to paint a false picture of the success of Bt cotton in India,” she claims.

The main objection is to the DBT becoming a regulator, especially when other ministries like MoEF, health, rural development and agriculture are also involved. “The DBT has a mandate to develop and promote the commerce of GMOs. It is one of the biggest funding agencies for the development of GMOs. To give it the role of regulation is a conflict of interest. Besides, the MoEF, which is the nodal agency for the Cartagena Protocol under the CBD on which the national regulation of GMOs is based, has the primary mandate to safeguard biosafety from their adverse impacts,” they say.

Most of the states are against field trials of GM crops. The legislation, in the current form, will take away their decision-making powers and reduce them to recommendatory capacity.

Responding to allegations that activists are anti-development, Bhushan says GM crops have not contributed to the betterment of anyone in the world other than developers and dealers of biotech seeds. “Bt cotton experience is a testimony to this. It is unfortunate that developers of the technology, including multinational seed companies like Monsanto, are not ready for a scientific debate on GMOs. It is the developers of GM crops who are not permitting the country to progress towards other progressive technologies and practices in agriculture like agroecology,” Bhushan claims.

Foreign hand

There is no evidence to prove that GM crops will make India self-sufficient in oilseeds or food. On allegations of foreign funds to oppose the Bill, he says if the government is worried about foreign money coming into the country, it should not be promoting public-private partnerships with multinational corporations for the development of GMOs. “Rather, the companies pose a threat to our seed sovereignty as seen in the case of cotton. Monsanto, the US multinational seed giant, controls almost 95 per cent of the cotton seeds in India through Bt cotton. The foreign hand argument is nothing but a ploy to deflect attention from the main debate on the negative impact of GM crops,” he says.

The Greenpeace accuses the GM lobby of pushing “the Malthusian argument that GM crops are a solution to food security to sell the controversial technology to the developing world. Our food grain production has been keeping pace with population growth. Nowhere in the world have GM crops helped increase food security. India destroyed its oilseed revolution by reducing the import duty. In 1993-94, India was self-sufficient in edible oils production, producing 97 per cent of the domestic needs. Import duty on crude edible oil was brought down to zero and refined edible oil to 7.5 per cent in 2010-11. No wonder, imports increased from 4.7 million tonnes in 2006 to 9.01 MT in 2012. Edible oil has got nothing to do with production, but our Agriculture Minister is under pressure from the World Bank to restructure the Indian economy,” says Neha.

Greenpeace, she says, is not against the technology, but the environmental release of GMOs. “The biotech industry is anti-development as it is not allowing the opportunity to explore other alternatives under biotechnology which could be more sustainable for agriculture than GMOs,” she claims.

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